ADVIL COLD AND SINUS: 76 Adverse Event Reports & Safety Profile
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76
Total FAERS Reports
0
Deaths Reported
0
Hospitalizations
76
As Primary/Secondary Suspect
First Report: 20120316 · Latest Report: 20140529
What Are the Most Common ADVIL COLD AND SINUS Side Effects?
#1 Most Reported
Drug ineffective
14 reports (18.4%)
#2 Most Reported
Therapeutic response unexpected
13 reports (17.1%)
#3 Most Reported
Somnolence
11 reports (14.5%)
All ADVIL COLD AND SINUS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 14 | 18.4% | 0 | 0 |
| Therapeutic response unexpected | 13 | 17.1% | 0 | 0 |
| Somnolence | 11 | 14.5% | 0 | 0 |
| Drug effect incomplete | 8 | 10.5% | 0 | 0 |
| Pre-existing condition improved | 8 | 10.5% | 0 | 0 |
| Off label use | 5 | 6.6% | 0 | 0 |
Who Reports ADVIL COLD AND SINUS Side Effects? Age & Gender Data
Average age: 52.4 years. Most reports from: US. View detailed demographics →
Is ADVIL COLD AND SINUS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 4 | 0 | 0 |
| 2013 | 3 | 0 | 0 |
| 2014 | 18 | 0 | 0 |
What Is ADVIL COLD AND SINUS Used For?
| Indication | Reports |
|---|---|
| Nasopharyngitis | 19 |
| Sinus disorder | 11 |
| Hypersensitivity | 6 |
| Sinus headache | 6 |
| Headache | 5 |
| Nasal congestion | 5 |
Official FDA Label for ADVIL COLD AND SINUS
Official prescribing information from the FDA-approved drug label.